Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-07-31

Brief Summary

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The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

1. conventional oxygen therapy (O2 conventional)
2. high flow nasal oxygen therapy (O2-HFN)
3. association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).

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Detailed Description

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Conditions

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Acute Lung Injury Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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O2 conventional : standard low flow therapy

in order to obtain a SpO2\>92%

Group Type ACTIVE_COMPARATOR

O2 conventional

Intervention Type OTHER

standard low flow therapy

O2-HNF : high flow nasal oxygen therapy

set between 30 to 50 l/min,adjusted in order to obtain a SpO2 \>92%.

Group Type EXPERIMENTAL

O2-HFN : high flow nasal oxygen therapy

Intervention Type DEVICE

The patient will receive high flow nasal of humidified oxygen, set between 30 to 50 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 \>92%.

O2-HFN/NPPV

cycling of NIV and O2-HDN

Group Type EXPERIMENTAL

O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation

Intervention Type DEVICE

The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 \>92% with the minimal FiO2.

Interventions

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O2 conventional

standard low flow therapy

Intervention Type OTHER

O2-HFN : high flow nasal oxygen therapy

The patient will receive high flow nasal of humidified oxygen, set between 30 to 50 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 \>92%.

Intervention Type DEVICE

O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation

The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 \>92% with the minimal FiO2.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hypoxemic and no hypercapnic acute respiratory failure :
* severe dyspnea at rest with a respiratory rate \>25 breaths/min
* PaO2/FiO2 \<300
* PaCO2 \<45 mmHg,

Exclusion Criteria

* age \<18 years
* NPPV contraindications
* past history of respiratory chronic disease (COPD, cystic fibrosis…)
* cardiac pulmonary edema
* Pre-defined intubation
* other than respiratory organ failure : systolic pressure \<90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
* profound aplasia (white cells count \<1000/mm 3)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No